New drug cocktail aims to stall colorectal cancer
NCT ID NCT05609370
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 4 times
Summary
This study tests whether adding two experimental drugs (LBL-007 and tislelizumab) to standard maintenance therapy can help control advanced colorectal cancer that has not spread widely. About 113 adults with unresectable or metastatic colorectal cancer will receive either the new combination or standard treatment alone. The goal is to see if the new approach delays cancer growth and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LBL-007 (Alcestobart) and Tislelizumab (BGB-A317) combined with Bevacizumab and Capecitabine or 5-Fluorouracil
- What this could lead to
- If successful, this could offer a new maintenance therapy option to help control advanced colorectal cancer for longer.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. Adding new drugs to standard therapy may increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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113 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must have measurable disease as defined per RECIST((Response Evaluation Criteria in Solid Tumors) version 1.1 * Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer \[AJCC\] 8th edition) * No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed * Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy Exclusion Criteria: * Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible * Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later * Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment * Any prior therapy targeting T-cell stimulation or checkpoint pathways * Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations * Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method Note: Other protocol defined criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974, United States
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Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234-2165, United States
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Baptist Health Lexington
Lexington, Kentucky, 40503-1466, United States
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Baptist Md Anderson Cancer Center
Jacksonville, Florida, 32207-8432, United States
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
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Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298, Australia
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Cancer Care Northwest
Spokane Valley, Washington, 99216-1020, United States
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Cancer Care Specialists
Reno, Nevada, 89511-2250, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
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Duke Cancer Center
Durham, North Carolina, 27710-2000, United States
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Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
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Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
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Helios Clinical Research
Cerritos, California, 90703, United States
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Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
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Hoag Memorial Presbyterian
Newport Beach, California, 92663-4162, United States
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Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
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Kaiser Permanente Northern California
Vallejo, California, 94589-2441, United States
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Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, 834009, China
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Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
New York, New York, 10016-2708, United States
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Linyi Peoples Hospital
Linyi, Shandong, 276000, China
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Monash Health
Clayton, Victoria, VIC 3168, Australia
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Multicare Health System Institute For Research and Innovation
Tacoma, Washington, 98405, United States
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Nantong First Peoples Hospital
Nantong, Jiangsu, 215124, China
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Norton Cancer Institute
Louisville, Kentucky, 40217-1395, United States
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429, United States
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One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
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Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales, NSW 2800, Australia
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Pan American Oncology Trials, Llc
Rio Piedras, 00935, Puerto Rico
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
Mineola, New York, 11501-3957, United States
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Pindara Private Hospital
Benowa, Queensland, QLD 4217, Australia
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Pontchartrain Cancer Center
Covington, Louisiana, 70433-7512, United States
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Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
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Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
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Riverina Cancer Care Centre
Wagga Wagga, New South Wales, NSW 2650, Australia
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Shandong Cancer Hospital
Jinan, Shandong, 250117, China
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Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123, China
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Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
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St John of God, Murdoch
Murdoch, Western Australia, WA 6150, Australia
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St Vincent Frontier Cancer Center
Billings, Montana, 59102-6746, United States
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The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
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The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
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The First Hospital of Jilin University
Changchun, Jilin, 130021, China
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
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The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
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The Xinjiang Uygur Autonomous Region Peoples Hospital
Ürümqi, Xinjiang, 830001, China
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin Municipality, 300121, China
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UCLA Hematologyoncology
Los Angeles, California, 90095-3075, United States
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University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536-7001, United States
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University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102-4517, United States
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University of Tennessee Medical Center
Knoxville, Tennessee, 37920-1511, United States
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Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019, United States
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Ut Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229-4427, United States
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Ut Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
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Valkyrie Clinical Trials
Los Angeles, California, 90067-2011, United States
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Virginia Cancer Specialists
Fairfax, Virginia, 22031-2171, United States
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Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China